Many medical procedures involve the extraction and replacement of flowing blood from, and back into, a donor or patient. The reasons for doing this vary, but generally, they involve subjecting the blood to some process that cannot be carried out inside the body. When the blood is outside the patient it is conducted through machinery that processes the blood. The various processes include, but are not limited to, hemodialysis, hemofiltration, hemodiafiltration, blood and blood component collection, plasmaphresis, aphresis, and blood oxygenation.
One technique for extracorporeal blood processing employs a single “access,” for example a single needle in the vein of the patient or a fistula. A volume of blood is cyclically drawn through the access at one time, processed, and then returned through the same access at another time. Single access systems are uncommon because they limit the rate of processing to half the capacity permitted by the access. As a result, two-access systems, in which blood is drawn from a first access, called an arterial access, and returned through a second access, called a venous access, are much faster and more common. These accesses include catheters, catheters with subcutaneous ports, fistulas, and grafts.
The processes listed above, and others, often involve the movement of large amounts of blood at a very high rate. For example, 500 ml of blood may be drawn out and replaced every minute, which is about 5% of the patient's entire supply. If a leak occurs in such a system, the patient could be drained of enough blood in a few minutes to cause loss of consciousness with death following soon thereafter. As a result, such extracorporeal blood circuits are normally used in very safe environments, such as hospitals and treatment centers, and attended by highly trained technicians and doctors nearby. Even with close supervision, a number of deaths occur in the United States every year due to undue blood loss from leaks.
Leaks present a very real risk. Leaks can occur for various reasons, among them: extraction of a needle, disconnection of a luer, poor manufacture of components, cuts in tubing, and leaks in a catheter. However, in terms of current technology, the most reliable solution to this risk, that of direct and constant trained supervision in a safe environment, has an enormous negative impact on the lifestyles of patients who require frequent treatment and on labor requirements of the institutions performing such therapies. Thus, there is a perennial need in the art for ultra-safe systems that can be used in a non-clinical setting and/or without the need for highly trained and expensive staff. Currently, there is great interest in ways of providing systems for patients to use at home. One of the risks for such systems is the danger of leaks. As a result, a number of companies have dedicated resources to the solution of the problem of leak detection.
In single-access systems, loss of blood through the patient access and blood circuit can be indirectly detected by detecting the infiltration of air during the draw cycle. Air is typically detected using an ultrasonic air detector on the tubing line, which detects air bubbles in the blood. The detection of air bubbles triggers the system to halt the pump and clamp the line to prevent air bubbles from being injected into the patient. Examples of such systems are described in U.S. Pat. Nos. 3,985,134, 4,614,590, and 5,120,303.
While detection of air infiltration is a reliable technique for detecting leaks in single access systems, the more attractive two-access systems, in which blood is drawn continuously from one access and returned continuously through another, present problems. While a disconnection or leak in the draw line can be sensed by detecting air infiltration, just as with the single needle system, a leak in the return line cannot be so detected. This problem has been addressed in a number of different ways, some of which are generally accepted in the industry.
The first level of protection against return line blood loss is the use of locking luers on all connections, as described in International Standard ISO 594-2 which help to minimize the possibility of spontaneous disconnection during treatment. Care in the connection and taping of lines to the patient's bodies is also a known strategy for minimizing this risk.
A higher level of protection is the provision of venous pressure monitoring, which detects a precipitous decrease in the venous line pressure. This technique is outlined in International Standard IEC 60601-2-16. This approach, although providing some additional protection, is not very robust, because most of the pressure loss in the venous line is in the needle used to access the patient. There is very little pressure change in the venous return line that can be detected in the event of a disconnection, so long as the needle remains attached to the return line. Thus, the pressure signal is very weak. The signal is no stronger for small leaks in the return line, where the pressure changes are too small to be detected with any reliability. One way to compensate for the low pressure signal is to make the system more sensitive, as described in U.S. Pat. No. 6,221,040, but this strategy can cause many false positives. It is inevitable that the sensitivity of the system will have to be traded against the burden of monitoring false alarms. Inevitably this leads to compromises in safety. In addition, pressure sensing methods cannot be used at all for detecting small leaks.
Yet another approach, described for example in PCT application US98/19266, is to place fluid detectors near the patient's access and/or on the floor under the patient. The system responds only after blood has leaked and collected in the vicinity of a fluid detector. A misplaced detector can defeat such a system and the path of a leak cannot be reliably predicted. For instance, a rivulet of blood may adhere to the patient's body and transfer blood to points remote from the detector. Even efforts to avoid this situation can be defeated by movement of the patient, deliberate or inadvertent (e.g., the unconscious movement of a sleeping patient).
Still another device for detecting leaks is described in U.S. Pat. No. 6,044,691. According to the description, the circuit is checked for leaks prior to the treatment operation. For example, a heated fluid may be run through the circuit and its leakage detected by means of a thermistor. The weakness of this approach is immediately apparent: there is no assurance that the system's integrity will persist, throughout the treatment cycle, as confirmed by the pre-treatment test. Thus, this method also fails to address the entire risk.
Yet another device for checking for leaks in return lines is described in U.S. Pat. No. 6,090,048. In the disclosed system, a pressure signal is sensed at the access and used to infer its integrity. The pressure wave may be the patient's pulse or it may be artificially generated by the pump. This approach cannot detect small leaks and is not very sensitive unless powerful pressure waves are used, in which case the effect can produce considerable discomfort in the patient.
Clearly detection of leaks by prior art methods fails to reduce the risk of dangerous blood loss to an acceptable level. In general, the risk of leakage-related deaths increases with the decrease in medical staff per patient driven by the high cost of trained staff. Currently, with lower staffing levels comes the increased risk of unattended leaks. Thus, there has been, and continues to be, a need in the prior art for a foolproof approach to detection of a return line leak or disconnection.
In an area unrelated to leak detection, U.S. Pat. No. 6,177,049 B1 suggests the idea of reversing the direction of blood flow for purposes of patency testing. The patent also states that flow reversal may be used to improve patency by clearing obstructed flow.
U.S. Pat. No. 6,572,576 discusses various embodiments of a blood treatment device where blood flow is reversed to provide leak detection. According to the inventions described, a leak detector effective to ensure detection of leaks in the venous blood line (the line returning blood to the patient) is provided by periodically generating a negative pressure, which may be brief or at a 50% duty cycle, in the blood return line. This draws air into the venous line which can be revealed by an air sensor in the blood treatment machine. During the negative pressure cycle, any air drawn in the venous blood line is detected, the system is shut down and an alarm generated. U.S. Pat. No. 6,572,576, filed Jul. 7, 2001 entitled “Method and apparatus for leak detection in a fluid line” is hereby incorporated by reference as if fully set forth in its entirety herein.
Hemofiltration, dialysis, hemodiafiltration, and other extracorporeal blood treatments may employ flow selector valves such as Y-valves, four-way valves, and other such devices for redirecting the flow of blood and other fluids such as replacement fluids. For example, the direction of the flow of blood through certain types of filters may be reversed repeatedly to prevent coagulation of blood in regions where the mean flow slows to very low rates. For example, where blood is circulated through tubular media in the context of a dialysis filter, it has been proposed that blood may coagulate on the surface of the inlet header leading to the progressive coagulation of blood. U.S. Pat. No. 5,605,630, proposes occasionally reversing the flow of blood through the filter. A four-way valve is proposed for changing over the flow direction.
In other references, the idea of reversing the flow of blood through a tubular media filter is discussed in connection with other issues. For example, in U.S. Pat. No. 5,894,011, the known technique of switching access lines in the patient to improve the flow through an occluded fistula is automated by the addition of a four-way valve on the patient-side blood circuit. In single-access systems in general, for example as described in U.S. Pat. No. 5,120,303, flow is conventionally reversed through the filter during each draw/return cycle. In the '303 reference, the specification observes that the efficiency of filtration is increased due to the double-passing of the same blood through the filter; that is, each volume of drawn blood is filtered twice. Yet another reference, U.S. Pat. No. 6,189,388 B1, discusses reversing the flow direction of blood through the patient access occasionally in order to quantify an undesirable short-circuit effect that attends their long term use. Still another U.S. Pat. No. 6,177,049 B1 suggests reversing flow through the draw access before treatment while an observer is present to test the accesses for patency or to clear blockage in the accesses.
Referring to FIGS. 1A through 1E, a number of alternative designs for four-way valves have been developed for blood circuits. Referring to FIG. 1A, U.S. Pat. No. 5,894,011, discloses a valve that swaps the connections between pairs of lines 905 and 906 via a pair of rotatably connected disks 901 and 902, each of which supports one of the pairs of lines 905 and 906. A seal must be maintained between the disks 901 and 902 and between the respective lines. The device is intended to be operated manually.
Referring to FIG. 1B, another four-way valve, disclosed in U.S. Pat. No. 5,605,630, which has been proposed for use in blood lines, has a rotating wheel 910 with channels 911 and 912 defined between the wheel 910 and the inside of a housing 913. When the wheel is rotated, the channels 911 and 912 shift to join a different pair of lines. This device also has seals.
Referring to FIG. 1C, another arrangement is proposed in U.S. Pat. No. 6,177,049. This device has a rotating component 915 with channels 921 and 922 defined within it. As the rotating component 915 is rotated, the channels defined between pairs of lines 917 and 919 change from parallel lines joining one set of corresponding lines to U-shaped channels joining a different set.
Referring to FIGS. 1D1 and 1D2, a design, disclosed in U.S. Pat. No. 4,885,087, is very similar to that of FIG. 1B. This design has a rotator 925 that connects different pairs of lines depending on the position thereby defining two different sets of possible flow channels 926 and 929 or 927 and 931.
In all of the above designs, the valves are not hermetically sealed. Any seal can be compromised, particularly by microorganisms. Thus, each of the foregoing designs suffers from that drawback. Also, many are expensive and do not lend themselves to automation.
Referring to FIG. 1E, another type of four-way valve is formed by interconnecting two tubes 937 and 938 with crossover lines 935 and 936. This design is disclosed in U.S. Pat. No. 6,189,388 (Hereafter, “U.S. Pat. No. '388”). Tube pinching actuators 941-944 are used to force fluid through different channels, depending on which actuators are closed. This device provides a hermetic seal and can be fairly inexpensive, but in a given configuration, significant no-flow areas are defined. These dead spaces can lead to the coagulation of blood, which is undesirable. Also, the interconnection of tubes in this does not lend itself to automated manufacturing.